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Harrow Licenses U.S. Rights to BYQLOVI™: A New Era in Ophthalmic Treatments

On June 9, 2025, Harrow (Nasdaq: HROW), a prominent name in North American eyecare pharmaceuticals, made headlines with its latest licensing agreement. The company has acquired exclusive U.S. commercial rights to BYQLOVI™ (clobetasol propionate ophthalmic suspension) 0.05%, a groundbreaking medication developed by Taiwan-based Formosa Pharmaceuticals (6838.TW). This agreement is anticipated to bring a new standard of care to patients recovering from ocular surgeries.

BYQLOVI™: A Transformative Product

BYQLOVI™ has recently secured approval from the U.S. Food and Drug Administration (FDA) for treating inflammation and pain that may occur after ocular surgery. What makes this particularly significant is that it is the first new ophthalmic steroid of its kind authorized for use in over 15 years. With the U.S. performing more than 7 million ophthalmic surgeries annually, the need for effective and safe treatment options has never been greater.

Mark L. Baum, CEO of Harrow, expressed enthusiasm about the new launch, stating, "We are thrilled to soon launch BYQLOVI, a truly clinically differentiated topical corticosteroid, into a U.S. market that now exceeds 7 million annual ophthalmic surgeries." Baum emphasized the medication's compelling efficacy and extraordinary safety profile, predicting that it has the potential to change the landscape of multimillion-dollar post-surgical ophthalmic care.

Formosa’s Commitment to Innovation

Erick Co, President and CEO of Formosa Pharmaceuticals, echoed these sentiments, highlighting the shared vision of both companies to enhance patient outcomes through innovative treatments. Co remarked, "Harrow's commitment to innovation, patient access, and physician engagement closely aligns with our mission to promote unique clinical advancements that improve patient outcomes."

Technical Excellence Behind BYQLOVI™

The clinical success of BYQLOVI™ is attributable to Formosa's proprietary APNT® nanoparticle formulation technology. This methodology ensures a highly uniform suspension that minimizes particle settling, optimizing consistent dosing for users. Upon clinical evaluation, BYQLOVI™ exhibited several key advantages:

• - Best-in-Class Pain Relief: In pivotal clinical studies, 77% to 85% of patients reported no pain four days post-surgery, with 82% to 87% indicating the same by day eight.
• - Outstanding Inflammation Clearance: Notably, 30% to 33% of participants recorded zero cell counts in the anterior chamber by day eight after surgery.
• - Safety Profile: Only 1.4% of patients experienced elevated intraocular pressure, a significant reduction compared to other ophthalmic steroids.
• - Dosing Convenience: Recommended usage is one drop twice daily for 14 days, eliminating the necessity for loading or maintenance doses.

Clinical Indications and Precautions

BYQLOVI™ is indicated specifically for the management of post-operative inflammation and pain following ocular surgery. However, physicians should exercise caution when prescribing due to certain contraindications. These include a history of active viral infections of the cornea and conjunctiva, mycobacterial eye infections, and fungal diseases affecting ocular structures.

Long-term use of steroids has been linked to increased intraocular pressure, potentially leading to conditions such as glaucoma if not monitored correctly. Therefore, practitioners are advised to conduct thorough patient evaluations and patient education regarding potential side effects, including delayed healing, rise in intraocular pressure, and risk of infections.

The Future of Ophthalmic Care

With the expected availability of BYQLOVI™ by the fourth quarter of 2025, Harrow and Formosa not only aim to address an existing market need but also to inspire confidence among surgeons and eyecare professionals. This strategic move embodies a commitment to improving post-surgical experiences for countless patients across the U.S. as they navigate their recovery journeys.

In conclusion, Harrow's acquisition of BYQLOVI™ is poised to revolutionize the approach to post-operative care in ophthalmology, paving the way for enhanced patient outcomes through scientifically-backed innovation. As we look ahead, the collaboration between established companies like Harrow and Formosa illustrates the power of partnership in driving advancements in healthcare.

For more information on BYQLOVI™ and its capabilities, visit Harrow's website and Formosa Pharmaceuticals.